Patient Satisfaction After Switching to Oral Testosterone Undecanoate

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    40
  • sponsor
    University of Miami
Updated on 8 August 2021

Summary

The purpose of this research study is to evaluate patient satisfaction with an oral testosterone agent, Jatenzo, compared to other forms of testosterone therapy.

Details
Condition Testosterone Deficiency
Treatment Jatenzo
Clinical Study IdentifierNCT04983940
SponsorUniversity of Miami
Last Modified on8 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntarily sign and date the study consent form(s) which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures
Males between 18 and 65 years of age
Documented diagnosis of testosterone deficiency
Prior treatment with testosterone therapy at the time of enrollment with adequate control of low testosterone symptoms. Serum total testosterone < 300 ng/dL on 2 measurements prior to the initiation of testosterone therapy. Patients must have completed an adequate washout period following prior testosterone therapy (4 weeks for gels and injection based therapies and 16 weeks for subcutaneous pellets)
Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG)

Exclusion Criteria

History of significant sensitivity or allergy to androgens or product excipients
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up or abnormal ECG
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points
Body mass index (BMI) 40 kg/m2
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to
Baseline hemoglobin > 16 g/dL
Hematocrit < 35% or > 50%
Poorly controlled blood pressure as defined by Systolic Blood Pressure (SBP) >150 or Diastolic Blood Pressure (DBP) > 90 on two separate measurements
Concurrent use of any prohibited medications that can affect testosterone levels or metabolism
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration
History of stroke or myocardial infarction within the past 5 years
History of, or current or suspected, prostate or breast cancer
History of, or current or suspected, pituitary abnormality
History of diagnosed, severe, untreated, obstructive sleep apnea
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years
Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment
Inability to understand and provide written informed consent for the study
Considered by the investigator or the sponsor-designated physician, for any reason, that the subject is an unsuitable candidate to receive Jatenzo
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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